Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
1 other identifier
interventional
47
1 country
8
Brief Summary
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2014
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedStudy Start
First participant enrolled
August 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2018
CompletedResults Posted
Study results publicly available
November 9, 2021
CompletedNovember 9, 2021
November 1, 2021
3.4 years
July 22, 2014
August 4, 2021
November 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months
TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).
Up to 90 weeks
Secondary Outcomes (10)
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC
Up to 36 weeks
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.
Up to 60 weeks.
Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein
Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated
Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance
Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
- +5 more secondary outcomes
Study Arms (2)
ARC001 placebo group
EXPERIMENTALSubjects who received placebo in study ARC001.
ARC001 AR101 group
EXPERIMENTALSubjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.
Interventions
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Eligibility Criteria
You may qualify if:
- Completion of ARC001 study
You may not qualify if:
- Early termination from ARC001
- Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
- A lapse in dosing of more than 10 days from completion of ARC001
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
UC San Diego
San Diego, California, 92123, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of North Carolina Chapel HIll
Chapel Hill, North Carolina, 25799, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Related Publications (1)
Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
PMID: 34389504DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Regulatory Affairs
- Organization
- Aimmune Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Director of Regulatory Affairs
Aimmune Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2014
First Posted
July 24, 2014
Study Start
August 27, 2014
Primary Completion
January 4, 2018
Study Completion
January 4, 2018
Last Updated
November 9, 2021
Results First Posted
November 9, 2021
Record last verified: 2021-11